METHOXSALENE MACOPHARM (méthoxsalène) - Lymphome cutané

Key points

Favourable opinion for reimbursement of METHOXSALEN MACOPHARMA (methoxsalen) solution, indicated in adults for extracorporeal use in the palliative treatment of advanced stage cutaneous T-cell lymphoma in patients who have not been responsive to other forms of treatment.

What therapeutic improvement?

No clinical added value in the therapeutic strategy on the basis of currently available data.

Role in the care pathway?

The first-line treatment of advanced stages (stages IIB, IIIA and IIIB) of cutaneous lymphoma, in which the 5-year survival rate is between 40 and 47%, is based on the use of systemic therapies (retinoids, IFN-α), which may be combined with local treatments along with low-dose MTX, TSEB or extracorporeal photopheresis. In the event of refractory disease, the guidelines suggest second-line treatment with gemcitabine or liposomal doxorubicin-based chemotherapy, multi-agent chemotherapy using the CHOP regimen or allogeneic haematopoietic stem cell transplantation in eligible patients.

Very advanced stages (IVA and IVB), which have a poor prognosis, are characterised by one or more skin tumours, combined, in the most severe cases, with generalised exfoliative dermatitis and palpable peripheral adenopathy. The 5-year survival rate is between 18 and 37%. For these very advanced stages, first-line treatment with single-agent chemotherapy (gemcitabine or liposomal doxorubicin) should be initiated straight away. In the event of an inadequate response or refractory disease, multiple-agent chemotherapy (CHOP regimen) or allogeneic haematopoietic stem cell transplantation should be envisaged. In the event of remission, irrespective of the stage, local or systemic maintenance therapy should be envisaged. Brentuximab vedotin (ADCETRIS) is a treatment for adult patients with MF not responding after at least one prior systemic therapy.

Role of the medicinal product in the care pathway:

The proprietary medicinal product METHOXSALEN MACOPHARMA (methoxsalen) is a palliative treatment in advanced stages of the disease in the event of non-response to other forms of treatment (PUVA therapy, systemic corticosteroids, chlormethine, interferon alpha, methotrexate).